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Feasibility and Efficacy of Delivering Blood Glucose Awareness Training Over the Internet

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Virginia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American Diabetes Association
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00327210
First received: May 16, 2006
Last updated: August 6, 2008
Last verified: August 2008
  Purpose

BGATHome is an interactive, web-based training program designed to improve the ability of adults with Type 1 Diabetes to recognize, predict, treat, and avoid extreme blood glucose (BG) events. It was developed at the University of Virginia over the past 20 years with funding from the National Institutes of Health and the American Diabetes Association. BGATHome provides important knowledge about personal insulin use, food, and activity regimens that influence BG levels. Users of this program will learn to monitor and recognize the cues that signal hyper and hypoglycemic events, and enhance their ability to control these fluctuations.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Behavioral: Blood Glucose Awareness Training
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Blood Glucose Awareness Training Delivered Over the Internet (BGATHome.Com): Feasibility and Efficacy

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Feasibility (Internet Evaluation conducted post intervention)

Secondary Outcome Measures:
  • Improved BG awareness
  • Reduced adverse events
  • Improved psychological functioning (Hypo Fear Survey, Diabetes Quality of Life)
  • Improved knowledge (Diabetes Knowledge Scale)
  • All measures administered pre and post intervention (post 1 year for experimental subjects)

Estimated Enrollment: 100
Study Start Date: May 2005
Estimated Study Completion Date: July 2009
Detailed Description:

Interested subjects will be informed that they will be randomly assigned to either receive the BGATHome program or will be placed in a wait-list control group. Respondents will be informed that if they are in the control group, they are expected to complete the pre- and post-assessments (HHC and questionnaires), but once these are complete, they will be given free access to the BGATHome program. Respondents will be informed that being in the control group will delay their access to the program by approximately 5 months.

A hand held computer (PDA) will be provided for use during this study. Subjects will be asked to first estimate their blood glucose level and enter this estimate into the PDA. They will then actually measure their blood glucose level and enter this actual value into the PDA also. This process of first estimating the blood glucose level and then taking an actual reading will be repeated 70 times during the 4-week period. The time estimated for this task is approximately 3 minutes for entering each estimate and measurement, or a total of 3.5 hours over the 4 weeks. The PDA device will be returned (postage paid) after the first 4 weeks of the study. At 12 weeks, the device will be sent to study subjects again and the process of obtaining data about blood glucose levels by first estimating and then taking an actual reading will be repeated over the next 4 weeks, as before. The PDA device will again be returned (postage paid) after 4 weeks of data collection. The total amount of time estimated to enter data into a PDA for this study is approximately 7 hours.

Subjects will be asked to respond to a series of four questionnaires on the Internet, taking approximately 30-45 minutes. These questionnaires will be completed 3 times over the course of the study - before beginning the BGATHome program, at 12 weeks and at one year after completing the BGATHome program. The total time estimated to complete the three sets of questionnaires is approximately 2 hours, 15 minutes.

Experimental subjects will be asked to complete a total of eight units of the BGATHome program, completing one unit a week except for the first week when two units will be completed. Each unit will take approximately one hour to complete. Subjects will have a maximum of 12 weeks to complete BGATHome. The total time is estimated at 8 hours.

The wait-list control subjects will be offered access to the BGATHome program approximately five months after consenting to be in the study. They will then complete the series of four questionnaires on the Internet 12 weeks after using the BGATHome program. If the control subjects do not choose to use the program, a one year follow assessment will occur like the experimental subjects.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes for at least one year.
  • Access to the Internet.
  • Routinely perform Self Monitoring of Blood Glucose at least three times a day.
  • ≥ 21 years of age

Exclusion Criteria:

- Not able to complete the Internet program in 12 weeks.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327210

Locations
United States, Virginia
University of Viginia Health System
Charlottesville, Virginia, United States, 22907
Sponsors and Collaborators
University of Virginia
American Diabetes Association
Investigators
Principal Investigator: Daniel J Cox, Ph.D University of Virginia Health System
  More Information

No publications provided by University of Virginia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00327210     History of Changes
Other Study ID Numbers: UVAIRB# 11593
Study First Received: May 16, 2006
Last Updated: August 6, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
BGAT
Blood Glucose Awareness Training
Diabetes
T1DM
Internet
Web
Intervention
Treatment
Behavior
Education
Awareness

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014